The following data is part of a premarket notification filed by Medtronic Sofamor Danek with the FDA for Zephir Anterior Cervical System.
| Device ID | K030327 |
| 510k Number | K030327 |
| Device Name: | ZEPHIR ANTERIOR CERVICAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Contact | Richard Treharne |
| Correspondent | Richard Treharne MEDTRONIC SOFAMOR DANEK 1800 PYRAMID PLACE Memphis, TN 38132 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-31 |
| Decision Date | 2003-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994544728 | K030327 | 000 |
| 00885074002415 | K030327 | 000 |
| 00885074002422 | K030327 | 000 |
| 00885074002439 | K030327 | 000 |
| 00885074002446 | K030327 | 000 |
| 00885074002453 | K030327 | 000 |
| 00885074002460 | K030327 | 000 |
| 00885074002477 | K030327 | 000 |
| 00721902610639 | K030327 | 000 |
| 00721902610653 | K030327 | 000 |
| 00721902610660 | K030327 | 000 |
| 00721902610677 | K030327 | 000 |
| 00721902610684 | K030327 | 000 |
| 00721902610691 | K030327 | 000 |
| 00721902610707 | K030327 | 000 |
| 00721902610714 | K030327 | 000 |
| 00613994544704 | K030327 | 000 |
| 00613994544711 | K030327 | 000 |
| 00885074002392 | K030327 | 000 |